Trial Outcomes & Findings for Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC (NCT NCT00746733)
NCT ID: NCT00746733
Last Updated: 2021-06-14
Results Overview
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0 through 96 hours after dosing
Results posted on
2021-06-14
Participant Flow
Open-label, randomized, four period crossover
Participant milestones
| Measure |
Vyvanse First
Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention.
|
Adderall XR First
Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
12
|
|
Second Intervention
COMPLETED
|
11
|
12
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
|
Third Intervention
STARTED
|
11
|
12
|
|
Third Intervention
COMPLETED
|
10
|
11
|
|
Third Intervention
NOT COMPLETED
|
1
|
1
|
|
Fourth Intervention
STARTED
|
10
|
11
|
|
Fourth Intervention
COMPLETED
|
10
|
11
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vyvanse First
Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention.
|
Adderall XR First
Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
|
|---|---|---|
|
Second Intervention
Adverse Event
|
1
|
0
|
|
Third Intervention
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 6.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
|
45.04 ng/ml
Standard Deviation 13.971
|
28.66 ng/ml
Standard Deviation 7.174
|
46.34 ng/ml
Standard Deviation 9.710
|
29.97 ng/ml
Standard Deviation 5.719
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
|
3.5 h
Standard Deviation 1.14
|
5.2 h
Standard Deviation 3.10
|
3.5 h
Standard Deviation 0.97
|
3.3 h
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
|
626.27 ng.h/ml
Standard Deviation 198.982
|
473.70 ng.h/ml
Standard Deviation 71.043
|
687.00 ng.h/ml
Standard Deviation 196.906
|
472.35 ng.h/ml
Standard Deviation 108.891
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
|
9.7 h
Standard Deviation 1.55
|
10.25 h
Standard Deviation 1.36
|
10.4 h
Standard Deviation 1.65
|
10.91 h
Standard Deviation 1.95
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
7.91 ng/ml
Standard Deviation 2.022
|
8.10 ng/ml
Standard Deviation 1.632
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
5.6 h
Standard Deviation 3.0
|
3.5 h
Standard Deviation 1.74
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
145.28 ng.h/ml
Standard Deviation 24.355
|
145.83 ng.h/ml
Standard Deviation 38.233
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
11.98 h
Standard Deviation 1.92
|
13.06 h
Standard Deviation 2.63
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
Total amphetamine is the d- and l-amphetamines.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
36.56 ng/ml
Standard Deviation 9.188
|
38.05 ng/ml
Standard Deviation 7.351
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
Total amphetamine is the d- and l-amphetamines.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
5.30 h
Standard Deviation 3.07
|
3.29 h
Standard Deviation 1.45
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
Total amphetamine is the d- and l-amphetamines.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
620.68 ng.h/ml
Standard Deviation 95.689
|
620.91 ng.h/ml
Standard Deviation 145.378
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 through 96 hours after dosingPopulation: PK population
Total amphetamine is the d- and l-amphetamines.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=23 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
|
10.38 h
Standard Deviation 1.56
|
11.05 h
Standard Deviation 2.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosingPopulation: Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.
Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
Pre-dose
|
1.0 units on a scale
Standard Deviation 0.0
|
1.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
0.5 h
|
1.2 units on a scale
Standard Deviation 0.60
|
2.0 units on a scale
Standard Deviation 3.09
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
1 h
|
1.8 units on a scale
Standard Deviation 1.75
|
2.0 units on a scale
Standard Deviation 3.08
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
1.5 h
|
4.6 units on a scale
Standard Deviation 8.28
|
2.2 units on a scale
Standard Deviation 3.56
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
2 h
|
4.6 units on a scale
Standard Deviation 8.33
|
2.5 units on a scale
Standard Deviation 4.56
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
2.5 h
|
3.9 units on a scale
Standard Deviation 6.04
|
2.3 units on a scale
Standard Deviation 3.73
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
3 h
|
3.5 units on a scale
Standard Deviation 5.78
|
1.5 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
3.5 h
|
2.7 units on a scale
Standard Deviation 3.78
|
1.3 units on a scale
Standard Deviation 0.80
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
4 h
|
1.7 units on a scale
Standard Deviation 1.06
|
1.4 units on a scale
Standard Deviation 0.86
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
5 h
|
2.4 units on a scale
Standard Deviation 3.93
|
1.3 units on a scale
Standard Deviation 0.72
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
6 h
|
1.4 units on a scale
Standard Deviation 0.81
|
1.2 units on a scale
Standard Deviation 0.51
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
8 h
|
1.4 units on a scale
Standard Deviation 0.74
|
1.3 units on a scale
Standard Deviation 1.32
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
12 h
|
1.2 units on a scale
Standard Deviation 0.62
|
1.1 units on a scale
Standard Deviation 0.36
|
—
|
—
|
|
Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
24 h
|
1.3 units on a scale
Standard Deviation 0.72
|
1.0 units on a scale
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosingPopulation: PD population
Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
Pre-dose
|
1.0 units on a scale
Standard Deviation 0.0
|
1.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
0.5 h
|
1.3 units on a scale
Standard Deviation 0.73
|
1.3 units on a scale
Standard Deviation 0.66
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
1 h
|
2.1 units on a scale
Standard Deviation 2.66
|
1.9 units on a scale
Standard Deviation 2.46
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
1.5 h
|
5.2 units on a scale
Standard Deviation 8.38
|
2.3 units on a scale
Standard Deviation 2.97
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
2 h
|
6.0 units on a scale
Standard Deviation 8.69
|
3.5 units on a scale
Standard Deviation 5.33
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
2.5 h
|
6.0 units on a scale
Standard Deviation 7.59
|
3.5 units on a scale
Standard Deviation 4.64
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
3 h
|
5.3 units on a scale
Standard Deviation 6.72
|
2.7 units on a scale
Standard Deviation 3.36
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
3.5 h
|
4.9 units on a scale
Standard Deviation 6.09
|
2.1 units on a scale
Standard Deviation 2.01
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
4 h
|
3.8 units on a scale
Standard Deviation 4.57
|
2.1 units on a scale
Standard Deviation 1.84
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
5 h
|
3.1 units on a scale
Standard Deviation 4.13
|
1.9 units on a scale
Standard Deviation 1.74
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
6 h
|
3.4 units on a scale
Standard Deviation 3.60
|
1.5 units on a scale
Standard Deviation 0.87
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
8 h
|
3.0 units on a scale
Standard Deviation 4.26
|
1.3 units on a scale
Standard Deviation 0.66
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
12 h
|
4.4 units on a scale
Standard Deviation 7.19
|
1.2 units on a scale
Standard Deviation 0.54
|
—
|
—
|
|
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
24 h
|
1.6 units on a scale
Standard Deviation 1.40
|
1.0 units on a scale
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosingPopulation: PD population
Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
Vyvanse + Prilosec OTC
|
Adderall XR + Prilosec OTC
|
|---|---|---|---|---|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
Pre-dose
|
1.0 units on a scale
Standard Deviation 0.0
|
1.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
0.5 h
|
2.0 units on a scale
Standard Deviation 3.49
|
2.1 units on a scale
Standard Deviation 3.11
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
1 h
|
1.8 units on a scale
Standard Deviation 1.67
|
2.0 units on a scale
Standard Deviation 3.08
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
1.5 h
|
4.3 units on a scale
Standard Deviation 8.03
|
1.8 units on a scale
Standard Deviation 1.55
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
2 h
|
4.5 units on a scale
Standard Deviation 8.37
|
1.4 units on a scale
Standard Deviation 0.93
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
2.5 h
|
3.8 units on a scale
Standard Deviation 6.39
|
1.4 units on a scale
Standard Deviation 0.80
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
3 h
|
3.4 units on a scale
Standard Deviation 5.78
|
1.2 units on a scale
Standard Deviation 0.54
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
3.5 h
|
2.6 units on a scale
Standard Deviation 3.54
|
1.3 units on a scale
Standard Deviation 0.72
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
4 h
|
1.8 units on a scale
Standard Deviation 1.18
|
1.3 units on a scale
Standard Deviation 0.80
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
5 h
|
2.3 units on a scale
Standard Deviation 4.13
|
1.3 units on a scale
Standard Deviation 0.97
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
6 h
|
1.6 units on a scale
Standard Deviation 1.02
|
1.2 units on a scale
Standard Deviation 0.70
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
8 h
|
1.6 units on a scale
Standard Deviation 1.78
|
1.1 units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
12 h
|
1.3 units on a scale
Standard Deviation 0.80
|
1.2 units on a scale
Standard Deviation 0.51
|
—
|
—
|
|
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
24 h
|
1.1 units on a scale
Standard Deviation 0.48
|
1.0 units on a scale
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosingPopulation: Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Pre-dose
|
115.6 mmHg
Standard Deviation 10.79
|
115.3 mmHg
Standard Deviation 10.26
|
114.8 mmHg
Standard Deviation 11.29
|
113.9 mmHg
Standard Deviation 11.71
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
1 h
|
122.8 mmHg
Standard Deviation 11.10
|
121.0 mmHg
Standard Deviation 10.46
|
121.7 mmHg
Standard Deviation 13.31
|
122.6 mmHg
Standard Deviation 9.67
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
2 h
|
127.9 mmHg
Standard Deviation 12.81
|
122.2 mmHg
Standard Deviation 11.34
|
125.5 mmHg
Standard Deviation 10.14
|
124.7 mmHg
Standard Deviation 12.74
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
4 h
|
127.6 mmHg
Standard Deviation 12.95
|
120.8 mmHg
Standard Deviation 11.71
|
125.2 mmHg
Standard Deviation 11.50
|
124.2 mmHg
Standard Deviation 9.75
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
8 h
|
126.0 mmHg
Standard Deviation 12.69
|
122.4 mmHg
Standard Deviation 11.04
|
123.5 mmHg
Standard Deviation 13.25
|
119.2 mmHg
Standard Deviation 10.99
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
12 h
|
123.4 mmHg
Standard Deviation 15.62
|
121.9 mmHg
Standard Deviation 12.04
|
122.2 mmHg
Standard Deviation 13.19
|
118.4 mmHg
Standard Deviation 10.58
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
24 h
|
114.0 mmHg
Standard Deviation 11.68
|
118.1 mmHg
Standard Deviation 12.97
|
114.7 mmHg
Standard Deviation 11.19
|
115.6 mmHg
Standard Deviation 13.42
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
48 h
|
114.6 mmHg
Standard Deviation 12.84
|
112.6 mmHg
Standard Deviation 10.56
|
114.4 mmHg
Standard Deviation 10.81
|
113.6 mmHg
Standard Deviation 11.01
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
72 h
|
113.7 mmHg
Standard Deviation 10.25
|
114.8 mmHg
Standard Deviation 11.81
|
115.1 mmHg
Standard Deviation 11.71
|
116.0 mmHg
Standard Deviation 9.74
|
|
Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
96 h
|
114.0 mmHg
Standard Deviation 10.53
|
114.5 mmHg
Standard Deviation 10.72
|
114.8 mmHg
Standard Deviation 11.06
|
116.1 mmHg
Standard Deviation 9.29
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosingPopulation: Safety population
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Pre-dose
|
76.0 mmHg
Standard Deviation 6.68
|
74.1 mmHg
Standard Deviation 6.72
|
77.7 mmHg
Standard Deviation 8.60
|
75.8 mmHg
Standard Deviation 7.80
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
1 h
|
79.2 mmHg
Standard Deviation 6.62
|
76.4 mmHg
Standard Deviation 5.98
|
80.5 mmHg
Standard Deviation 9.52
|
80.4 mmHg
Standard Deviation 6.29
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
2 h
|
79.0 mmHg
Standard Deviation 6.97
|
75.4 mmHg
Standard Deviation 6.58
|
82.0 mmHg
Standard Deviation 6.44
|
81.9 mmHg
Standard Deviation 8.71
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
4 h
|
79.9 mmHg
Standard Deviation 7.91
|
77.7 mmHg
Standard Deviation 6.31
|
82.0 mmHg
Standard Deviation 7.68
|
82.0 mmHg
Standard Deviation 7.09
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
8 h
|
78.6 mmHg
Standard Deviation 7.87
|
74.1 mmHg
Standard Deviation 5.73
|
80.3 mmHg
Standard Deviation 9.54
|
79.2 mmHg
Standard Deviation 7.96
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
12 h
|
79.6 mmHg
Standard Deviation 9.45
|
78.5 mmHg
Standard Deviation 8.29
|
78.7 mmHg
Standard Deviation 10.47
|
77.8 mmHg
Standard Deviation 8.20
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
24 h
|
75.9 mmHg
Standard Deviation 6.76
|
76.8 mmHg
Standard Deviation 8.62
|
75.0 mmHg
Standard Deviation 7.76
|
75.4 mmHg
Standard Deviation 7.30
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
48 h
|
74.5 mmHg
Standard Deviation 8.39
|
73.5 mmHg
Standard Deviation 8.40
|
77.2 mmHg
Standard Deviation 6.53
|
74.4 mmHg
Standard Deviation 8.01
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
72 h
|
75.1 mmHg
Standard Deviation 7.97
|
74.7 mmHg
Standard Deviation 7.24
|
76.1 mmHg
Standard Deviation 7.58
|
77.9 mmHg
Standard Deviation 6.77
|
|
Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
96 h
|
74.5 mmHg
Standard Deviation 8.02
|
75.7 mmHg
Standard Deviation 7.65
|
75.7 mmHg
Standard Deviation 7.48
|
78.3 mmHg
Standard Deviation 6.96
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosingPopulation: Safety population
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
96 h
|
70.7 bpm
Standard Deviation 10.64
|
70.4 bpm
Standard Deviation 9.11
|
72.5 bpm
Standard Deviation 10.12
|
73.9 bpm
Standard Deviation 9.86
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Pre-dose
|
70.9 bpm
Standard Deviation 9.87
|
69.0 bpm
Standard Deviation 8.87
|
73.3 bpm
Standard Deviation 10.16
|
71.4 bpm
Standard Deviation 10.14
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
1 h
|
69.7 bpm
Standard Deviation 10.61
|
70.0 bpm
Standard Deviation 11.29
|
73.4 bpm
Standard Deviation 10.91
|
73.8 bpm
Standard Deviation 13.78
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
2 h
|
78.2 bpm
Standard Deviation 11.64
|
75.2 bpm
Standard Deviation 10.85
|
83.4 bpm
Standard Deviation 14.68
|
80.5 bpm
Standard Deviation 16.87
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
4 h
|
79.0 bpm
Standard Deviation 14.40
|
74.5 bpm
Standard Deviation 12.62
|
84.4 bpm
Standard Deviation 16.29
|
78.4 bpm
Standard Deviation 15.03
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
8 h
|
84.8 bpm
Standard Deviation 11.38
|
79.1 bpm
Standard Deviation 10.70
|
87.7 bpm
Standard Deviation 14.34
|
81.5 bpm
Standard Deviation 11.50
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
12 h
|
86.4 bpm
Standard Deviation 13.84
|
82.3 bpm
Standard Deviation 14.12
|
89.1 bpm
Standard Deviation 13.77
|
82.7 bpm
Standard Deviation 10.99
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
24 h
|
79.9 bpm
Standard Deviation 11.19
|
74.7 bpm
Standard Deviation 12.58
|
80.4 bpm
Standard Deviation 11.32
|
76.4 bpm
Standard Deviation 12.06
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
48 h
|
73.2 bpm
Standard Deviation 11.28
|
74.0 bpm
Standard Deviation 11.02
|
75.1 bpm
Standard Deviation 10.32
|
75.0 bpm
Standard Deviation 9.46
|
|
Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
72 h
|
72.2 bpm
Standard Deviation 10.63
|
73.3 bpm
Standard Deviation 9.16
|
72.0 bpm
Standard Deviation 7.99
|
72.7 bpm
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours after dosingPopulation: Safety population
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Outcome measures
| Measure |
Vyvanse + Prilosec OTC
n=24 Participants
|
Adderall XR + Prilosec OTC
n=23 Participants
|
Vyvanse + Prilosec OTC
n=21 Participants
|
Adderall XR + Prilosec OTC
n=21 Participants
|
|---|---|---|---|---|
|
Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
8 h
|
390.0 msec
Standard Deviation 12.45
|
393.8 msec
Standard Deviation 13.94
|
395.4 msec
Standard Deviation 14.93
|
394.4 msec
Standard Deviation 13.26
|
|
Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Pre-dose
|
399.8 msec
Standard Deviation 14.55
|
398.3 msec
Standard Deviation 15.24
|
399.3 msec
Standard Deviation 13.38
|
399.8 msec
Standard Deviation 15.04
|
|
Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
2 h
|
395.0 msec
Standard Deviation 14.11
|
394.6 msec
Standard Deviation 13.42
|
397.9 msec
Standard Deviation 13.86
|
396.1 msec
Standard Deviation 14.49
|
Adverse Events
Vyvanse
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Adderall XR
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vyvanse + Prilosec OTC
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Adderall XR + Prilosec OTC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vyvanse
n=24 participants at risk
|
Adderall XR
n=23 participants at risk
|
Vyvanse + Prilosec OTC
n=21 participants at risk
|
Adderall XR + Prilosec OTC
n=21 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
8.3%
2/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
0.00%
0/21
|
0.00%
0/21
|
|
Cardiac disorders
Tachycardia
|
8.3%
2/24 • Number of events 2
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/21
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
9.5%
2/21 • Number of events 2
|
0.00%
0/21
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
14.3%
3/21 • Number of events 3
|
0.00%
0/21
|
|
Psychiatric disorders
Anxiety
|
8.3%
2/24 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
38.1%
8/21 • Number of events 9
|
0.00%
0/21
|
|
Vascular disorders
Vasospasm
|
0.00%
0/24
|
0.00%
0/23
|
19.0%
4/21 • Number of events 4
|
14.3%
3/21 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER